S5 Mast Roller Pump 85 — Class II medical device recall Z-0273-2013

Terminated recall by Sorin Group USA, Inc., reported 2012-11-14, distributed nationwide. Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin G

Recall number	`Z-0273-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Sorin Group USA, Inc., Arvada, CO, United States
Recall initiated	2012-09-19
Classified	2012-11-08
Reported by FDA	2012-11-14
Terminated	2013-01-18
Distributed	Nationwide (US)
Countries outside the US	AT, AU, BE, CA, CN, DE, DK, ES, FI, GB, IE, IN, IR, JP, LB, MA, PK, PL, TH, TR, ZA
Quantity	3 units
Reason classes	specification failure
Serial numbers	`50E50766--50E50769`, `50E50772-50E50774`, `50E50783-50E50784`
Model numbers	`10-88-60`

Product

S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

Reason for recall

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0273-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.